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U.S. Department of Health and Human Services

Class 2 Device Recall Coulter LH500 Hematology Analyzer

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  Class 2 Device Recall Coulter LH500 Hematology Analyzer see related information
Date Initiated by Firm April 17, 2006
Date Posted July 18, 2006
Recall Status1 Terminated 3 on April 19, 2012
Recall Number Z-1245-06
Recall Event ID 35602
510(K)Number K032000  
Product Classification Device, General Purpose, Hematology - Product Code LOQ
Product Coulter LH500 Hematology Analyzer: Part Numbers 178832, 178833, 178834
Code Information All software versions.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information Contact Eri H. Hirumi
714-961-4389
Manufacturer Reason
for Recall		 Beckman has confirmed that erroneous results could be reported when the workstation database crashes.
FDA Determined
Cause 2		 Other
Action A Product Corrective Action (PCA) letter was sent week of April 17, 2006 via US mail. The letter outlines action to be taken to avoid potential erroneous results. Firm targeting 75% effectivenss checks.
Quantity in Commerce 759
Distribution Nationwide and Canada
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LOQ and Original Applicant = BECKMAN COULTER, INC.
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